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Premedication to Reduce Discomfort With Screening Mammography

This study has been completed.
Sponsor:
Information provided by:
Mountain States Tumor and Medical Research Institute
ClinicalTrials.gov Identifier:
NCT00382083
First received: September 26, 2006
Last updated: September 27, 2006
Last verified: September 2006
  Purpose

This study will explore the effect of pre-medication with acetaminophen, ibuprofen, and topical lidocaine gel (Topicaine) on the perception of discomfort and overall satisfaction with the mammography experience.

The research questions are:

  1. What is the relationship between the use of acetaminophen, ibuprofen, and Topicaine prior to screening mammography and the perception of discomfort during the procedure?
  2. What is the relationship between perception of discomfort and overall satisfaction with the mammography experience?
  3. What is the relationship between the perception of discomfort and plans for future mammograms?
  4. What other factors are associated with the perception of discomfort and satisfaction?

Condition Intervention Phase
Breast Pain
Drug: 1000 mg acetaminophen
Drug: 800 mg ibuprofen
Drug: 1 oz 4% lidocaine gel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Mountain States Tumor and Medical Research Institute:

Primary Outcome Measures:
  • Discomfort scores on a visual analog scale at recruitment, at enrollment, and after mammogram
  • Satisfaction scores on a visual analog scale after mammogram

Secondary Outcome Measures:
  • Pre-mammogram anxiety scores on a visual anxiety scale at enrollment
  • Pre-mammogram breast tenderness scores on a visual analog scale at enrollment

Study Start Date: March 2006
Estimated Study Completion Date: June 2006
Detailed Description:

Breast cancer is prevalent, deadly, costly, and has low cure rates unless detected in its early stages. Mammography is the key component to early detection, yet it remains underutilized due to cost, access, and factors such as fear of pain.

Multiple studies have shown that most women find mammography uncomfortable, even painful. Yet, little research has been done to find methods to reduce mammography-related discomfort. In an unpublished Master’s thesis, this investigator found that women who expected discomfort > 40 on a visual analog scale (VAS) who were pre-medicated with 1000 mg of acetaminophen reported lower discomfort scores than those pre-medicated with placebo, but the sample size was too small to reach statistical significance. Further study on the effects of pre-medication is needed.

Pain should not be associated with a potentially lifesaving procedure. A more comfortable and positive experience with mammography may increase the number of women who participate in regular mammography screening, and, thereby, increase early detection and reduce the mortality rate, costs, and emotional trauma associated with breast cancer.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women scheduled for age-appropriate screening mammography at St. Luke's Breast Cancer Detection Center
  • Expect discomfort of 40 or greater on a scale of 0-100
  • Willing to arrive 1 hour early for appointment to enroll in study

Exclusion Criteria:

Women who:

  • expect discomfort from their mammogram to be < 40 on a scale of 0-100
  • cannot understand or read English or who are unable to complete the consent process or questionnaire for reasons such as hearing impairment or other physical or mental disabilities
  • have a sensitivity or allergy to acetaminophen, ibuprofen, or lidocaine
  • have significant liver or kidney dysfunction
  • are breast-feeding
  • cannot arrive a minimum of 60 minutes earlier than their appointment time
  • have taken any pain relief medications within 24 hours of their mammogram appointment, including over-the-counter medications.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00382083

Locations
United States, Idaho
St. Luke's Mountain States Tumor Institute Breast Cancer Detection Center
Boise, Idaho, United States, 83712
Sponsors and Collaborators
Mountain States Tumor and Medical Research Institute
Investigators
Principal Investigator: Colleen K. Lambertz, MSN, FNP Mountain States Oncology Group
Study Chair: Paul G Montgomery, MD St. Luke's Mountain States Tumor Institute
Study Director: Theodore A Walters, MD Mountain States Tumor Medical Research Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00382083     History of Changes
Other Study ID Numbers: MSTMRI - 001
Study First Received: September 26, 2006
Last Updated: September 27, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Mountain States Tumor and Medical Research Institute:
Mammogram
Pain
Discomfort
Breast
Pre-medication

Additional relevant MeSH terms:
Acetaminophen
Analgesics
Analgesics, Non-Narcotic
Antipyretics
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014